Tissue treatment device for an extremity

ABSTRACT

A tissue treatment device suitable for use on an extremity or a portion of an extremity, such as a hand or foot, includes a cover formed as a bag, sac, or pouch, and a flexible, absorbent support member. Defined sections of the support member may be removed from the support member to form an opening therein. The support member is for being positioned within the cover to support a portion of the cover off of, and out of contact with, tissue to be treated. The cover has an open end with attachment means disposed thereon for attachment to the extremity or extremity portion that is received in the cover. The support member may be impregnated with a medicament. The removable sections allow formation of an opening that may be customized or adapted to the area of tissue that is to receive treatment. This permits the tissue treatment device to be adapted for use with treatment areas that vary in size, shape, contour, and composition.

This application is a continuation-in-part of U.S. patent applicationSer. No. 09/908,152, filed Jul. 18, 2001, now U.S. Pat. No. 6,573,420entitled TISSUE TREATMENT DEVICE FOR A LIMB, which is a continuation ofU.S. patent application Ser. No. 09/437,388, filed Nov. 10, 1999, nowU.S. Pat. No. 6,323,386, entitled WOUND COVERING FOR A FOOT OR HAND.

FIELD OF THE INVENTION

The invention described herein relates to a tissue treatment device, andin particular, to a tissue treatment device capable of being configuredin a clinical setting to provide a cover out of contact with tissue tobe treated on an awkwardly shaped body part, such as a foot, or a hand,that is capable of delivering heat to the wound. The invention moreparticularly relates to a tissue treatment device having a flexible,absorbent support member in a bag-like cover for being positioned nearthe tissue to be treated. Particularly, the invention concerns such atissue treatment device having a flexible, absorbent support member thatincludes defined sections that are removable from the support member toenable the formation of openings in the support member which vary inshape and size.

BACKGROUND OF THE INVENTION

A novel mode of tissue treatment employing a non-contact treatmentdevice is disclosed in U.S. Pat. Nos. 5,817,145; 5,947,914 and6,093,160, each of which is owned in common with the present applicationand is hereby incorporated by this reference. The device has a centralopening between two surfaces for forming a treatment volume against anarea of tissue to be treated when one of the surfaces is disposedagainst tissue surrounding the area without the opening encompassing alimb. The treatment volume is covered at the surface not contactingtissue in order to control parameters of the ambient environment in thetreatment volume that are indicated in the treatment to which the tissueis to be subjected. Some of these parameters are temperature, moisture,and treatment materials such as medicaments. The device is particularlyeffective in treating wounds and reducing infection.

Typically, such a treatment device includes, in addition to otherelements, a support member, an attachment portion, and a bag-like cover.

The support member generally comprises a standoff with an opening. Theattachment portion is for acting between a 'skin surface and thestandoff to connect and retain the treatment device on the skin of apatient, with the opening aimed at an area to be treated along a linethat passes through the area. The cover spans the opening, away from thepatient's skin surface. Together the standoff and cover define atreatment volume which projects along the intersecting line onto apatient's skin surface, in a two-dimensional area when the device ismounted to the patient's skin. This device is referred to as a“non-contact” device because, when attached to skin, it surrounds anarea where treatment is to be applied in such a way that no portion ofthe device, save the treatment volume, contacts the area.

A novel mode of treatment for an extremity portion such as a foot or ahand which extends the principles of non-contact treatment is disclosedin applicant's U.S. Pat. No. 6,323,386 B1, WOUND COVERING FOR A FOOT ORHAND, which is owned in common with the present application and ishereby incorporated by this reference. This non-contact device includesa flexible, absorbent support member, an attachment portion, and a coverformed as a bag, sac, or pouch. The support member is for being disposedwithin the cover to support a portion of the cover off of, and out ofcontact with, an area of tissue to be treated. The support memberincludes an opening for being aimed at an area where treatment is to beapplied along a line that intersects the area. Once the support memberis formed, the size and shape of the opening cannot be changed withoutcutting the support member. Thus, when such a treatment device isreceived for use in the clinic, the tissue area where treatment is to beapplied may be larger than the opening, or may have a shape notaccommodated by the shape of the opening. In addition, there may bemultiple adjacent areas where treatment is to be applied which, for onereason or another, need separate treatment volumes but cannot beaccommodated by multiple support members. In such cases, one size ofopening probably will not fit all needs, and it may be necessary for avariety of such treatment devices to be inventoried in order to realizeflexibility in treatment.

A need exists, therefore, for a tissue treatment device for use onextremities or extremity portions such as hands or feet in which asupport member can be adapted for various sizes, shapes, and numbers oftissue areas where treatment is to be applied. In particular, it wouldbe desirable for the treatment device to be provided with a supportmember accommodating of one or more treatment areas of different sizesand shapes.

SUMMARY OF THE INVENTION

The present invention is a treatment device that is particularly wellsuited to treating tissue on an extremity of a patient, such as the handor foot. The treatment device is useful, for example, to treat tissue orwounds that commonly occur on a patient's extremities, and areparticularly difficult to treat.

The invention is a non-contact tissue treatment device having a coverformed as a bag, sac, or pouch, one or more flexible attachmentportions, and at least one flexible, absorbent support member capable ofhaving one or more openings made in it of varying shapes and sizes. Inthis regard, the support member includes a plurality of defined sectionswhich may be arranged in a pattern. One or more of the sections may beselectively removed to form at least one opening through the supportmember. The removable sections allow formation of an opening that may becustomized or adapted to the area of tissue that is to receivetreatment. This permits the tissue treatment device to be adapted foruse with treatment areas that vary in size, shape, contour, andcomposition.

BRIEF DESCRIPTION OF THE DRAWINGS

The various figures depict illustrative and exemplary forms of thetissue treatment device disclosed herein. Throughout the several views,identical reference numbers represent similar or equivalent structures.

FIG. 1 is a perspective view of one embodiment of the tissue treatmentdevice in combination with a heating system.

FIG. 2 is an exploded view of one embodiment of the tissue treatmentdevice showing an exemplary construction.

FIG. 3 is an exploded view of another embodiment of the tissue treatmentdevice.

FIGS. 4 and 5 are perspective views of the tissue treatment device ofFIG. 3 with an extremity.

FIG. 6 is an exploded view of still another embodiment of the tissuetreatment device.

DETAILED DESCRIPTION

Reference is made in this description to tissue treatment and to atissue treatment area. In this regard, “treatment” is meant in itsbroadest sense. That is, treatment with the tissue treatment devicedescribed herein is the rendering of medical aid to tissue. At the sametime, the device also functions to protect tissue which is beingtreated. A “treatment area” is an area that is defined by an element ofthe tissue treatment device when the device is deployed for use and thatis to receive a treatment provided by the device. The treatment area mayinclude one or more wounds and associated periwound tissue. Thetreatment area may also be an unwounded area of tissue.

Refer now to FIGS. 1–6 in which embodiments and elements of the presenttissue treatment device are illustrated. With respect to FIGS. 1 and 2,there is shown a tissue treatment device 8 that includes a cover 9formed as a bag, sac, or pouch with an open end, and a flexibleabsorbent support member 10. The cover may be constructed from twosheets of material, although this construction is merely forillustration and is not intended to limit the construction of the cover9. In this construction, the cover 9 includes a first sheet 11 and asecond sheet 12, each of approximately the same size and shape. Thefirst sheet 11 has an edge 13 and an end 14. The second sheet 12likewise has an edge 15 and an end 16. A continuous seal 17 is formedbetween the first and the second edges 13 and 15, joining the two sheets11 and 12. Together the joined sheets form an enclosure that can fitover an extremity. The enclosure has an open end 14, 16 through whichthe extremity can extend. Alternatively, the cover 9 may be made from asingle sheet of flexible material, or otherwise formed as a single,unseamed member.

Preferably the material of which the cover 9 is made is a flexible,easily worked material that is adaptable to automated manufacturing.Such synthetic materials as flexible plastics are examples. Othermaterials such as woven and non-woven synthetics, natural, or blendedmaterials are contemplated. The chosen material may be clear or opaque.

The tissue treatment device 8 further comprises attachment portions 18,19, which are disposed along the end 14, 16. The attachment portions areused to connect the tissue treatment device 8 to the skin of a patient,sealing the enclosure formed by the cover 9 to a patient's extremity asillustrated in FIG. 2. In FIGS. 2, 4 and 5, the extremity is a foot 6 onthe bottom of which is a wound 7.

Referring now to FIG. 2, in the tissue treatment device 8, theattachment portions 18, 19 are integrated unitary assemblies, eachpreferably having three sections: a foam layer 32, an adhesive filmlayer 33 on a bottom surface of the foam layer 32, and a release liner34 covering the adhesive film layer 33. One or more lines of weakness orperforation are provided on the release liner 34 so that its parts maybe separated and selectably peeled off of the adhesive film layer 33,thereby exposing the adhesive film layer for attaching to a patient'sskin. The foam layer 32 may comprise a naturally open-celledpolyurethane foam, and is preferably approximately 1/16″ thick. Theadhesive film layer 33 may comprise a high MVTR thin film pressuresensitive adhesive (PSA) laminate available as a package under the tradename Mediderm from Bertek. The foam layer 32 is heat bonded to theadhesive film layer 33. The material of which the adhesive film layer iscomprised is selected for a combination of adhesion level, permeability,and conformability (stretching and flexing with the skin) to allowprolonged skin contact without complications. An example of an adhesivematerial is Avery Dennison's med 5666R sold under the tradenameWetstick. The release liner 34 is a white release paper coated with arelease agent. An alternative adhesive film is the Mediderm 3701product. The perforations or slits are made during assembly to aid inthe removal of the release liner 34 prior to attachment of a tissuetreatment device 8 to a person.

The tissue treatment device 8 further comprises a support member 10 forsupporting a portion of the cover 9 off of or away from an area oftissue where treatment is to be applied so as to prevent the coverportion from contacting the tissue (or at least to minimize suchcontact). Lack of contact between the area and the cover 9 is useful,for example, when a wound to is in the area to be treated. In theembodiment illustrated in FIGS. 1 and 2, the support member 10 is in theshape of a ring. The support member 10 has a central opening 20, a firstsurface 22, a second surface 23 (not visible in the figures), and anouter perimeter or edge 24. A portion of the inner surface of the cover9 may be attached to the first surface 22 of the support member 10 asdescribed below. The cover 9 is preferably sized to extend beyond theouter perimeter 24 of the support member 10 as illustrated in FIGS. 1and 2.

The support member 10 may be formed of a foam material, preferably anabsorbent foam. An example of a suitable absorbent foam is a naturallyopen-celled polyurethane foam that is selected to have favorablecharacteristics of liquid absorbency, leaking, and resevoiring. Suchmaterial is a super absorbent polymer (SAP) filled foam, which may beobtained from Neosorb, Woodbridge, Md. Alternative materials availableinclude products sold under the trade names Aquazone from Foamex,Medisponge from Lendell Manufacturing, and Medical SAP foam from RynelLtd. The thickness of the ring-shaped support member 10 is preferably ina range extending from ⅜″ to ⅝″, with the exact dimension being selectedto maintain the cover off of an area of tissue where treatment is to beapplied such as an area 7 of skin on the foot 6 whereby, during use, thefoam ring 10 can compress and conform without the cover 9 contacting thearea 7.

Medicament may be stored in a reservoir of the support member 10, forexample, by impregnating the support member 10 itself with medicament,such as an antibiotic, antifungal, or antimicrobrial material. It mayalso be desirable to impregnate the support member with a deodorantmaterial or a material to release nitric oxide. In any case, thematerial or materials with which the support member is impregnated, orsome one or more constituents of those materials, will passively diffuseover the area in order to control the environment in the treatmentvolume formed over or against the area.

In use, the support member 10 is positioned on a skin surface portionwith the opening aimed at the area 7 along a line which passes throughthe area. In this manner, the opening is projected onto the skin wherethe support member is placed, around the area to be treated.

The second surface 23 of the support member 10 may optionally have amoisture barrier film adhered thereto. Such a moisture barrier filmallows for smooth contact between the support member 10 and thepatient's skin and may prevent maceration of the skin if the supportmember 10 is wetted by soaking up wound exudate. Optionally, the filmmay be porous or perforated to allow exudate to be wicked away from theskin and trapped in the foam material of the support member 10. Anymoisture barrier film would be suitable, in particular those composed ofpolyurethane, polyethylene, and the like. The film may be attached tothe second surface 23 by means of heat sealing or a ring of adhesive,such as the product sold under the trade name HL-2306-X by H. B. FullerAdhesive.

The material of the cover 9 preferably is a 2 mil.-thick clear flexiblepolyurethane film with favorable characteristics selected, but notlimited, to include moisture vapor transfer (MVTR), oxygen permeability,and transmission of infrared radiation. A measurable MVTR isparticularly desirable when the tissue treatment apparatus is deployedover hands and feet, which sweat profusely. Such material is availablesold under the trade name Deerfield 6100S or Omniflex TX1530, the latterproviding a preferred surface for adhesion of the stretcher 25. Theportion of the inner surface of the cover 9 is attached to the uppersurface 22 of the support member 10 by a ring of adhesive comprising asynthetic rubber-base adhesive, such as the product sold under the tradename HL-2306-X. Alternatively, the inner surface of the cover 9 may beheat sealed to the upper surface 22 of the support member 10.

A stretcher layer 25 may be attached to the outer surface of the cover 9against the support member 10 such that the cover 9 is sandwichedbetween the stretcher layer 25 and the first surface 22 of the supportmember 10. The stretcher layer 25 is a 5 mil-thick planar sheet of(preferably) clear, somewhat flexible polyester film having enoughstiffness to aid in maintaining planarity. The function of the stretcherlayer 25 is to hold the portion of the cover 9 under it taut, much as a“stretcher frame” tautens an artist's canvas. The stretcher layer 25 isattached to the cover 9 by a layer of adhesive comprising a clearflexible polyester carrier film coated on both sides with an aggressiveadhesive. The adhesive layer is oriented over the first surface 22 ofthe support member 10. The stretcher layer 25 further includes a pair ofslits 35 that receive a detachable heater 30. With the provision of theslits 35, a pocket is formed between the stretcher layer 25 and thecover 9.

FIG. 1 shows a detachable heater 30 positioned to slide into a slit 35in the stretcher layer 25 which forms a pocket with the cover 9. Wheninserted, the heater 30 is supported substantially in a plane or surfaceabove a wound by the support member 10. The heater 30 is generallyplanar and may be connected to and powered by a portable power supply31, such as those heaters described in detail in U.S. Pat. Nos.5,954,680, 5,964,723 and 5,986,163, each of which is owned in commonwith the present application and are hereby incorporated by thisreference. The application of heat may be of particular therapeuticbenefit by improving cellular physiologic functions, immune competence,and perfusion in the wound area.

Another embodiment of the present invention is illustrated in FIGS. 3–5,where is shown a tissue treatment device 108 that includes a cover 109formed as a bag, sac, or pouch, with an open end, and a support member110. As explained above with reference to FIGS. 1 and 2, the cover maybe constructed from two sheets of material, although this constructionis merely for illustration and is not intended to so limit theconstruction of the cover 109. In this construction, the cover 109includes a first sheet 111 and a second sheet 112, each of approximatelythe same size and shape. The first sheet 111 has an edge 113 and an end114. The second sheet 112 likewise has an edge 115 and an end 116. Acontinuous seal 117 is formed between the first and the second edges 113and 115, joining the two sheets 111 and 112. Together the joined sheetsform an enclosure that can fit over an extremity. Alternatively, thecover 109 may be made from a single sheet of flexible material, orformed as a single member. The enclosure has an open end through whichthe extremity can extend. Once over the extremity, the enclosure may besealed around the extremity if desired.

Preferably the material of which the cover 109 is made is a flexible,easily worked material that is adaptable to automated manufacturing.Such synthetic materials as flexible plastics are examples. Othermaterials such as woven and non-woven synthetics, natural, or blendedmaterials are contemplated. The chosen material may be clear or opaque.

The tissue treatment device 108 further comprises attachment portions118, 119, which are disposed along the end 114, 116. The attachmentportions are used to connect the tissue treatment device 108 to apatient's extremity, as illustrated in FIGS. 4 and 5. In FIGS. 4 and 5,the extremity is a foot 106 on the bottom of which one or more wounds107 a and 107 b are illustrated.

Referring now to FIG. 3, in the tissue treatment device 108, theattachment portions 118, 119 may be made of adhesive strips, such astape. In the figures shown, the tape is a integrated unitary assemblyhaving three sections: a foam layer 132, an adhesive film layer 133 on abottom surface of the foam layer 132, and a release liner 134 coveringthe adhesive film layer 133. The foam layer 132 may comprise a naturallyopen-celled polyurethane foam. One or more lines of weakness orperforation are provided on the release liner 134 so that its parts maybe separated and selectably peeled off of the adhesive film layer 133,thereby exposing the adhesive film layer for attaching to a patient'sskin. The perforations or slits are made during assembly to aid in theremoval of the release liner 134 prior to attachment of a tissuetreatment device 108 to a person.

When the tissue treatment device 108 is put over the patient'sextremity, the open end of the cover may need to be sealed around theextremity. As shown in FIGS. 4 and 5, once the tissue treatment device108 is in position, the attachment portions 118 and 119 are attached tothe extremity, in this case the foot 106. Then the end portions 118 aand 199 a of the attachment portions 118 and 119 are pinched together toseal the tissue treatment device 108 over the extremity 106 and helpkeep it in place.

The tissue treatment device 108 disclosed herein includes a supportmember 110 for supporting a portion of the cover 109 off of or away fromthe area of tissue where treatment is to be applied so as to prevent thecover portion from contacting the area (or at least to minimize suchcontact). In the embodiments illustrated in FIGS. 3–6, the supportmembers 110 and 210 are in the shape of a disc, although this is notmeant as a limitation. The support member 110 may have an initiallyclosed area composed of a plurality of removable sections 121 which maybe selectively removed to form one or more openings in the supportmember 110. In FIGS. 3–5, these sections are formed as regular cubesdisposed in a two-dimensional matrix from which they may be removed.Such forms and shapes are not necessary to the invention. For examplethe removable sections may be formed as concentric rings as taught inU.S. Pat. No. 6,143,945, which has been incorporated herein byreference. In FIG. 3, one of the removable sections 121 is shownremoved, thereby forming an initial opening 120. In addition, thesupport member 110 has a first surface 122, a second surface 123 (notvisible in the figures), and an outer perimeter or edge 124. A portionof the inner surface of the cover 109 may be attached to the firstsurface 122 of the support member 110 as described below, against anopening formed in the support member, to form a treatment volume 126therewith. The cover 109 is preferably sized to extend beyond the outerperimeter 124 of the support member 110 as illustrated in FIGS. 3–5. Theremovable sections 121 may be defined by a sharp-edged form broughtagainst one of the surfaces 122, 123 to cut part way into the supportmember 110, without penetrating it, or by cutters that penetratecompletely portions of the support member leaving some portions uncut.The sections can also be formed by molding the support member in aframe.

An opening may be formed in the support member 110 that is adjustable insize and shape, so that it may be tailored to fit one or more treatmentareas that vary in size or shape. In this regard, one or more of theremovable sections 121 may be removed to create an opening. For example,shown in FIG. 4, approximately 11 removable sections 121 are removedfrom the lower right side of the initial opening 120 to accommodate awound 107 a. FIG. 5 shows another example where approximately 14removable sections 121 comprising the center three rows of thering-shaped support member 110 are removed to accommodate three wounds107 b. As can be appreciated, there are openings of many other shapes,sizes and configurations that can be made by removing one or more of theremovable sections 121.

The support member 110 is preferably made of a foam material, preferablyan absorbent foam. An example of a suitable absorbent foam is anaturally open-celled polyurethane foam that is selected to havefavorable characteristics of liquid absorbency, wicking, andresevoiring, as described in reference to support member 10. Medicamentmay be stored in a reservoir of the support member 10, for example, byimpregnating, infusing, spraying or disposing on the support member 10itself with medicament, such as an antibiotic, antifungal, orantimicrobrial material. It may also be desirable to impregnate, infuse,spray or dispose on the support member with a deodorant material or amaterial to release nitric oxide. In any case, the material or materialswith which the support member is impregnated, or some one or moreconstituents of those materials, will passively diffuse over the area inorder to control the environment in the treatment volume formed over oragainst the area. The application of heat by means of a heater such asthe heater 30 may assist the diffusion or activity of the medicaments.There also may be some type of containment system, such as a removablecover, bag or tape, that prevents the materials from dispersing ordiffusing from the foam prior to use. The thickness of the ring-shapedsupport member 110 is dimensioned to maintain the cover off of atreatment area 107 whereby, during use, the support member 110 cancompress and conform without the cover 109 contacting the area.

In use, the support member 110 is positioned on a skin surface portionwith the opening aimed at the treatment area 107 along a line whichpasses through the area. In this manner, the opening is projected ontothe skin where the support member is placed, around the area to betreated.

The second surface 123 of the ring-shaped support member 110 mayoptionally have a moisture barrier film adhered thereto. Such a moisturebarrier film allows for smooth contact between the support member 110and the patient's skin and may prevent maceration of the skin if thesupport member 110 is wetted by soaking up wound exudate. Optionally,the film may be porous or perforated to allow exudate to be wicked awayfrom the skin and trapped in the foam material of the support member110. Any moisture barrier film would be suitable, in particular thosecomposed of polyurethane, polyethylene, and the like. The film may beattached to the, second surface 123 by means of heat sealing or a ringof adhesive.

The material of the cover 109 is the same as that of cover 9, which ispreferably a clear flexible polyurethane film with favorablecharacteristics selected, but not limited, to include moisture vaportransfer (MVTR), oxygen permeability, and transmission of infraredradiation. A measurable MVTR is particularly desirable when the tissuetreatment apparatus is deployed over hands and feet, which sweatprofusely. The portion of the inner surface of the cover 109 is attachedto the upper surface 122 of the support member 110 by a ring ofadhesive.

A stretcher layer 125 may be attached to the outer surface of the cover109 against the support member 110 such that the cover is sandwichedbetween the stretcher layer 125 and the first surface 122 of the supportmember 110. The stretcher layer 125 is preferably clear and somewhatflexible film having enough stiffness to aid in maintaining planarity.The function of the stretcher layer 125 is to hold the portion of thecover 109 under it taut, much as a “stretcher frame” tautens an artist'scanvas. The stretcher layer 125 is attached to the cover 109 over thetreatment volume 126 by a layer of adhesive and a pocket is formedbetween the stretcher layer 125 and the cover 109. The stretcher layer125 further includes one or more slits 135 to access the pocket. Thepocket can be used for different applications, such as holding adetachable heater 30 (as described and shown in conjunction with FIG.1).

Along a top portion of the cover 109 a short adhesive strip 127 may beplaced. The strip 127 may have a release liner 128 covering the adhesivelayer. Once the cover 109 is placed over the extremity 106, there may besome excess cover or film 109 a at the closed end of the cover 109. Ifthere is, it may be gathered by the adhesive strip 127. In this regard,the release liner 128 is removed and the excess film 109 a is foldedover the extremity 106 and held to the cover 109 by the adhesive strip127, as shown in FIGS. 4 and 5.

Another embodiment of a tissue treatment device 208 is illustrated inFIG. 6, which is similar in design and construction to the tissuetreatment device 108, with similar components using similar referencenumbers. FIG. 6 shows an exploded view of the tissue treatment device208 for use on an extremity including cover 109, described above inconnection with the tissue treatment device 108.

The tissue treatment device 208 further comprises a support member 210,which is similar to the support member 110 in design, construction andfunction. The support member 210 has an opening 220, a plurality ofremovable sections 221 around the central opening 220, a first surface222 and a second surface 223 (not visible in the figures). The supportmember 210 is made of a flexible foam material and may have treatmentmaterials stored in a reservoir, such as described above for the supportmember 110. The inner surface of the support member 210 may optionallybe all or partially modified by having a moisture barrier film adheredthereto, as described for the support member 110 above.

The removable sections that surround the opening 220 in the supportmember 210 are for adjusting the size and shape of the opening, so thatit may be tailored to fit the size and shape of different treatmentareas. One or more of the removable sections 221 may be removed tocreate a larger or shaped opening 220. Proximate the central opening 220is an annulus-shaped removable section 221 a that is removable in foursections. Proximate the removable section 221 a are four cornerremovable sections 221 b. As can be understood, one or more of theremovable sections 221 a and 221 b may be removed to create a larger orshaped opening 220. For example, if all the removable sections 221 a,221 b were removed, the support member 210 would be very similar lookingto the support member 10 shown in FIG. 2, having a rectangular centeropening.

A portion of the inner surface 222 is attached to the cover 109,generally in the same manner and using similar materials as describedabove for support member 110, forming a similar treatment volume. Thesecond surface 223 of the ring-shaped support member 210 may optionallyhave a moisture barrier film adhered thereto, the same as describedabove for support member 110.

The following describes use of the tissue treatment devices disclosed.Presume that the tissue to which treatment to be applied is, orcontains, a wound. In this case, the tissue to be treated is cleaned,including the area around the wound (the “periwound”). A skin protectoror sealant may be applied to the periwound area to protect it fromexudates and adhesives. The wound is measured to determine the sizeopening required in the support member. It is preferred that the edgesof the opening be near but not touching the wound. If enlargement isneeded, one or more of the plurality of removable sections or segmentsof the support member are removed to create an appropriately sized andshaped opening. The cover is slid over the extremity and positioned sothe wound can be seen through the window. With the wound in the window,the adhesive liner is removed on the window side of the wound cover andthe adhesive is pressed against the skin. The adhesive should be smoothto help it stick to the skin and make an adequate seal. Then the otheradhesive liner is removed and the adhesive is pressed firmly against theskin. The ends of the adhesive strips are pinched together to seal thecover and help keep in it place. If there is excess film at the top ofthe cover, a short adhesive strip is used to adjust the fit. The lineris removed from the short adhesive strip, the excess film is folded overand the short adhesive strip is attached to the cover. The tissuetreatment device is now in place. The heater or warming card may beactivated. In addition, medicaments that may be stored in the supportmember may now be released.

While the invention has been illustrated by means of specificembodiments and examples of use, it will be evident to those skilled inthe art that many variations and modifications may be made thereinwithout deviating from the scope and spirit of the invention. However,it is to be understood that the scope of the present invention is to belimited only by the appended claims.

1. A tissue treatment device, comprising: a bag-like cover with an openend; an absorbent support member for being positioned within the cover;a plurality of removable sections in the support member for beingremoved to provide an opening through the support member; a medicamentstored in the support member for being released into the opening; alayer of material joined to the outer surface of the cover; a pocketbetween the layer of material and the cover; and at least one slit inthe layer which opens into the pocket.
 2. The tissue treatment device ofclaim 1, wherein the medicament is selected from the group consisting ofan antibiotic material, an antifungal material, an antimicrobrialmaterial, a deodorant material and nitric oxide.
 3. The tissue treatmentdevice of claim 1, wherein the support member comprises a ring-shapedfoam member.
 4. The tissue treatment device of claim 1, wherein thesupport member comprises a rectangular foam member.
 5. The tissuetreatment device of claim 1 further comprising one or more attachmentportions disposed along the open end.
 6. The tissue treatment device ofclaim 1, wherein the support member has a first surface and a secondsurface, the cover has an inner surface and an outer surface and thefirst surface of the support member has means for attachment to theinner surface of the cover.
 7. The tissue treatment device of claim 1further comprising a heater for being disposed in the pocket.
 8. Thetissue treatment device of claim 7 further comprising a power supply forbeing connected to the heater.
 9. A tissue treatment device, comprising:a bag-like cover with an open end; a support member with a centralopening for being positioned within the cover; a plurality of removablesections in the support member, surrounding the central opening; thesupport member having a first surface and a second surface; the coverhaving an inner surface; the first surface of the support member havingmeans for attachment to the inner surface of the cover; and a flexible,non-adhesive material attached to the second surface of the supportmember.
 10. The tissue treatment device of claim 9, wherein the supportmember has the shape of a ring.
 11. The tissue treatment device of claim10, wherein the support member is made of an absorbent foam material.12. The tissue treatment device of claim 11 further comprising atreatment material disposed in the foam material for being released intothe opening to treat tissue.
 13. The tissue treatment device of claim12, wherein the treatment material is selected from the group consistingof an antibiotic material, an antifungal material, an antimicrobrialmaterial, a deodorant material and nitric oxide.
 14. The tissuetreatment device of claim 9 further comprising a moisture barrier filmattached to the second surface of the support member.
 15. The tissuetreatment device of claim 14, wherein the moisture barrier film isporous.
 16. The tissue treatment device of claim 9 further comprising alayer of material disposed against an outer surface of the cover. 17.The tissue treatment device of claim 16 further comprising: a pocketbetween layer of material and the cover; and at least one slit openinginto the pocket.
 18. The tissue treatment device of claim 17 furthercomprising a heater for being disposed in the pocket.
 19. The tissuetreatment device of claim 18 further comprising a power supply for beingconnected to the heater.
 20. The tissue treatment device of claim 9further comprising one or more attachment portions disposed along theopen end.
 21. The tissue treatment device of claim 20, wherein the oneor more attachment portions each includes an adhesive material.
 22. Thetissue treatment device of claim 21, wherein the one or more attachmentportions each includes a backing layer of foam material, the adhesivematerial carried on a surface of the foam material.
 23. The tissuetreatment device of claim 22, wherein the one or more attachmentportions include a release layer carried on the adhesive material. 24.The tissue treatment device of claim 23, wherein the release layer hasone or more lines of weakness for permitting a portion of the releaselayer to be removed from the adhesive material.
 25. The tissue treatmentdevice of claim 20, wherein the one or more attachment portions iscapable of sealing the cover to the extremity forming a sealedenclosure.
 26. The tissue treatment device of claim 9, wherein the coveris formed from a single sheet of flexible material.
 27. The tissuetreatment device of claim 9, the cover comprising two opposing sheets ofmaterial joined along a portion of their respective edges.
 28. Thetissue treatment device of claim 27, each sheet comprising a 2 mil.thick film of polyurethane.
 29. A method for treating tissue on apatient's extremity with a tissue treatment device, the tissue treatmentdevice including: a bag-like cover with an open end; one or moreattachment portions disposed along the open end; and an absorbentsupport member having a plurality of removable sections; the methodcomprising: removing one or more of the plurality of removable sectionsto form an opening in the support member; with the support memberreceived in the bag-like cover, placing the tissue treatment device overthe patient's extremity; positioning the opening over the tissue to betreated; and attaching the tissue treatment device to the patient'sextremity with one or more attachment portions.
 30. The method of claim29, further including storing a treatment material in the supportmember.
 31. The method of claim 30 further comprising releasing thetreatment material, or constituents of the treatment material, from thesupport member through the opening.
 32. The method of claim 31, whereinthe treatment material is selected from the group consisting of anantibiotic material, an antifungal material, an antimicrobrial material,a deodorant material and nitric oxide.
 33. The method of claim 31,wherein storing a treatment material includes impregnating the absorbentsupport member with a medicament.
 34. The method of claim 29, whereinattaching the tissue treatment device includes sealing the tissuetreatment device to the patient's extremity.
 35. The method of claim 29,wherein the tissue treatment device further includes: an outer surfaceon the cover; a layer of material attached to the outer surface of thecover; at least one slit in the layer of material.
 36. The method ofclaim 35 further comprising inserting a heater through the slit.
 37. Themethod of claim 36 further comprising operating the heater.
 38. Themethod of claim 29 further including releasing a treatment material, orconstituents of the treatment material, from the support member throughthe opening.
 39. The method of claim 38, wherein the treatment materialis selected from the group consisting of an antibiotic material, anantifungal material, an antimicrobrial material, a deodorant materialand nitric oxide.